The FDA sent to the Office of Management and Budget (OMB) a proposed rule that would require food companies to clearly label the color additives carmine and cochineal extract used in food products, according the OMB's website.

The notice states OMB is scheduled to review the proposed rule by January. OMB received the proposal October 27. FDA says its action is based on adverse event reports of allergic reactions to the color additives and a 1998 citizen petition urging the agency to require labels to declare the allergens in food and other products.

Cochineal extract and carmine are derived from female cochineal beetles. The extract provides a pink, red or purple color to foods, as noted in a 1998 statement by the Center for Science in the Public Interest (CSPI).

In August 1998, the CSPI petitioned the agency to require labeling for cochineal extract and carmine color additives. CSPI asked that the additives be labeled by name and origin in ingredient lists of foods, drugs and cosmetics. The group wanted FDA to ban the use of the extracts if deemed necessary.

In the petition, CSPI also asked FDA to undertake scientific studies to determine the specific allergenic component of cochineal extract and carmine, as well the maximum severity of allergic reactions.

Research shows the additives could cause hives, sneezing, rhinitis and anaphylactic reactions, according to CSPI. Currently these additives may be declared in labels as "artificial color" or "color added." CSPI suggested that ingredient lists carry the statement: "Artificial color (carmine/cochineal extract [insect based])."

This statement would warn vegetarians and people with dietary restrictions that the food contains an insect-based coloring agent, the group said.